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Trial registered on ANZCTR
Registration number
ACTRN12616001280493
Ethics application status
Approved
Date submitted
30/08/2016
Date registered
12/09/2016
Date last updated
12/09/2016
Type of registration
Prospectively registered
Titles & IDs
Public title
Partnering with Patients in Medication Administration: Testing the effect of a information brochure for patients on medication administration errors
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Scientific title
Testing the effect of a medication information brochure for general medical patients, in the hospital setting, on medication administration errors
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Secondary ID [1]
290052
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None
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Universal Trial Number (UTN)
U1111-1187-0346
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Trial acronym
PPMA
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Medication error
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Condition category
Condition code
Injuries and Accidents
299988
299988
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0
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Other injuries and accidents
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
An information brochure, co-produced with consumer advisors and health professionals, to describe in lay language the checking procedure that nurses are required to follow when administering medications in the hospital setting.
Research staff will distribute the brochure by hand to all patients who meet the inclusion criteria within 24 hours of their admission to an intervention ward. The brochure will remain with the patient for the duration of their inpatient stay. Patients in the usual care wards will not receive the brochure.
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Intervention code [1]
295774
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Other interventions
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Comparator / control treatment
The comparator group will not receive the brochure.
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Control group
Active
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Outcomes
Primary outcome [1]
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Primary outcome 1. Medication errors measuring using medication chart audits.
With a 10% medication administration error rate, a 95% CI and 80% power, to detect an anticipated 5% error reduction rate, Approximately, 600 medication orders in each arm per audit cycle will be audited.
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Assessment method [1]
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Timepoint [1]
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Timepoint: Audits will be carried out on all four wards on a single day each month for 3-months prior, 3-months during, and 3-months post intervention.
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Primary outcome [2]
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Primary outcome 2: Medication errors reported in RiskMan (risk management system).
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Assessment method [2]
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Timepoint [2]
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Timepoint: For all four wards, monthly reports of RiskMan data will be obtained for 4-months prior, 3-months during, and 4-months post intervention.
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Primary outcome [3]
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Primary outcome 3: Observations of nurses’ medication administration practices. Non-participant observation will be conducted by a member of the research team who will not interact with the nurse or patient and will remain as discrete as possible. Observation periods will be of 2-hours duration and will be conducted at typical medication administration times (e.g., 0800, 1400, 2000). A total of 200 administration episodes will be observed in each ward during each of the three phases. A structured data collection tool will be used during the observation.
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Assessment method [3]
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Timepoint [3]
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Timepoint: For the 3-months pre, during and post intervention, observations of medication administration by nurses will be undertaken on the four wards.
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Secondary outcome [1]
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Secondary outcome 1: Patient perceptions of whether they exercised the right to ask if the checking procedure had been followed. A semi-structured telephone interview will be conducted by research personnel to elicit patients’ perceptions.
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Assessment method [1]
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Timepoint [1]
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Timepoint: Interview conducted at approximately 48 hours post discharge.
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Secondary outcome [2]
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Secondary outcome 2: Focus group interviews will be conducted with registered nurses and medication endorsed enrolled nurses on each of the intervention wards to elicit their perceptions of the acceptability of the patient engagement intervention and its effect on patient behaviour. One to three focus group interviews will be conducted on each ward, dependent on the number and availability of nurses willing to participate in an interview.
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Assessment method [2]
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Timepoint [2]
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Timepoint: The focus groups will be undertaken within the first three months following completion of the intervention.
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Eligibility
Key inclusion criteria
Patients:
Admitted to a general ward where the research is being conducted
Aged 18 years or more
Ability to communicate in English
Cognitive capacity to read and understand the participant information and consent form, and provide informed consent, and complete an interview and/or survey
Received and read the patient brochure (interview patients only)
Staff:
Employed on the ward in which the research is being conducted and working during the intervention period
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Not admitted to the included wards
Less than 18 years of age
Not able to communicate clearly in English
Cognitive impairment limiting capacity to read and understand the participant information and consent form, and provide informed consent, and complete an interview and/or survey
Did not receive and read the patient brochure (interview patients only)
Staff:
Not working on the ward in which the research is being conducted during the intervention period
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation at ward level concealed. A statistician who was not familiar with the wards that were eligible to receive the intervention was provided with a list of ward codes and used a web-based randomisation generator (http://www.randomization.com) to determine which wards would receive the intervention.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation at ward level only. Simple randomisation was undertaken using a randomisation table created by computer software - 4 subjects randomized into 2 blocks.
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
Sample size based on number of charts audited for medication error. Medication error is key dependent variable.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
12/09/2016
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Actual
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Date of last participant enrolment
Anticipated
31/01/2017
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Actual
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Date of last data collection
Anticipated
31/03/2017
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Actual
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Sample size
Target
7200
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Accrual to date
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Final
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Funding & Sponsors
Funding source category [1]
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Other
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Name [1]
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Nurses Board of Victoria Legacy Limited
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Address [1]
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NBVLL Secretariat
PO Box 327
Wendouree VIC 3355
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Country [1]
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Australia
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Primary sponsor type
Individual
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Name
Alison Hutchinson
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Address
School of Nursing and Midwifery
Deakin University
221 Burwood Highway
Burwood VIC 3125
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Country
Australia
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Secondary sponsor category [1]
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University
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Name [1]
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Deakin University
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Address [1]
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75 Pigdons Rd, Waurn Ponds VIC 3216
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Country [1]
293369
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Monash Health HREC
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Ethics committee address [1]
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Monash Medical Centre 246 Clayton Rd, Clayton VIC 3168
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
295849
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Approval date [1]
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15/03/2016
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Ethics approval number [1]
295849
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16091A
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Ethics committee name [2]
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Deakin University HREC
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Ethics committee address [2]
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Deakin University 75 Pigdons Rd, Waurn Ponds VIC 3216
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Ethics committee country [2]
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Australia
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Date submitted for ethics approval [2]
295850
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Approval date [2]
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12/04/2016
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Ethics approval number [2]
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2016-115
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Summary
Brief summary
Primary objectives To determine (1) the feasibility of the KT patient engagement intervention and study design, and (2) the effect of the patient engagement intervention on medication administration error rates. Secondary objectives To determine (1) patients’ and nurses’ perceptions of the acceptability of the KT patient engagement intervention, and (2) the effect of the intervention on nurses’ and patients’ behaviour. The intervention The basis of this knowledge translation (KT) patient engagement intervention will be a patient brochure containing information about the required medication administration checking procedures, developed in consultation with consumer representatives and clinical nurse representatives. Four general wards across two hospitals will be included: two intervention wards (i.e., brochure) and two control wards (i.e., usual practice/no brochure). Research staff will distribute the brochure to patients within 24 hours of their admission to the intervention wards. Their attention will be drawn to the content of the brochure and their right to ask the nurse if the checking procedure has been adhered to. The brochure will remain with the patient for the duration of their inpatient stay. Outcome data Data on medication administration errors will be obtained from three different sources: Medication chart audits: Carried out on all four wards on a single day each month for 3-months prior, 3-months during, and 3-months post intervention. RiskMan medication error data: For all four wards, monthly reports of RiskMan data will be obtained for 4-months prior, 3-months during, and 4-months post intervention. Random observations of nurses’ medication administration practices: For the 3-months pre, during and post intervention, observations of medication administration by nurses will be undertaken on the four wards. Process evaluation data Patient interview: Approximately 48-hours following discharge from intervention wards (consent will be obtained prior to discharge), a telephone interview will be conducted to elicit patients’ perceptions of the brochure and whether it had any effect on their behaviour. Patient survey: Patients discharged from all four wards during the 3-month intervention phase will be invited to complete a survey, primarily focused on their confidence to manage their health and their involvement and engagement in their own care. Staff focus group interview: Registered nurses and medication endorsed enrolled nurses on intervention wards will be invited to participate in a focus group interview to determine their perceptions of the intervention.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Alison Hutchinson
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Address
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School of Nursing and Midwifery
Deakin University - Burwood
221 Burwood Highway
Burwood, Victoria, 3125
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Country
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Australia
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Phone
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+61 3 9244 6446
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Fax
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Email
68690
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[email protected]
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Contact person for public queries
Name
68691
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Alison Hutchinson
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Address
68691
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School of Nursing and Midwifery
Deakin University - Burwood
221 Burwood Highway
Burwood, Victoria, 3125
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Country
68691
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Australia
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Phone
68691
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+61 3 9244 6446
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Fax
68691
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Email
68691
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[email protected]
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Contact person for scientific queries
Name
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Alison Hutchinson
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Address
68692
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School of Nursing and Midwifery
Deakin University - Burwood
221 Burwood Highway
Burwood, Victoria, 3125
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Country
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Australia
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Phone
68692
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+61 3 9244 6446
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Fax
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Email
68692
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[email protected]
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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